Method of filling suture package



Feb. 2, 1965 v. c. EGLER ETAL 3,167,395

METHOD OF FILLING SUTURE PACKAGE Original Filed June 3, 1958 Z/ CINVENTORS.

W BY M R.

United States Patent Ofifice I 3,167,895 Patented Feb. 2, 1965 This invention is concerned with packages for coils of relatively still resilient suture strands. More particularly.

it is concerned with relatively fiat suture coil packages which, in addition to dispensing the suture progressively without entanglement and with a minimum of kinking, have particular utility in surgical ligating procedures.

The' Surgical field has long been in need of a device which could eliminate time consuming practices and curtail-.a great deal of the'handling of sutures in preparation 1 for ligating. The practice today is one involving removparallel to the face, have reduced the kinking problem considerably particularly the four prong, circular coil reel. Furthermore, their flat nature makes them more suitable for insertion into relatively flat envelope type suture outer packages which are currently preferred by many surgeons to standard glass tubes. But none of these presently utilized reels have solved the ligating problem because when the prongs of these reels are bent or broken to make the suture available, the entire coil loosens and thereby tends to come oii the reel-at once.

It is one of the objects of this invention to provide a combination suture-dispensing andligating package for ing the suture from the reel, stretchingit to remove the V bends, severing it into shortflengthsf to prevent tangling, coiling these short lengths loosely so that the surgeon can hold the loose coil in his hand or alternatively winding the length onto, albobbin which the surgeon holds in 2 his hand. 'All of this must be done. under aseptic conditions. Thereafter'the surgeon uses each short length until I panying drawings in which:

it is too short to make s'trongknots after which perhaps as much-as Alof the-original length is discarded.

There have been some early previous attempts. tov

solve this ligating probler'mone or which is illustrated in U.S. Patent' No. 2,284,724 to Cleminson. Cleininson had: i

to resort to undesirable heat-settingfof his fsju'tu're into 'a spring-like coil in 1 order: to prevent 'tangling'since his.

s'uture'i's dangling free in'thetubel Furthermore, the

Cleminson device is" impractical'lforiligatingpurposes be-' cau'sc the' sharp broken edges of the. tube would-cut the surgeons glove and hand it heldin 'thepa'lm' for ligating. Another attempt to solve this ligating problem is illustrated in FIGSL3 and fl of"U.S. Patent No. .1",33 4,9l6 to, Lukens. The tight coilswhich 'the tubes, illustrated in this patent (and'in Ithe Cleminsonipatent), impose upon when the suture is dispensed from the side. Wei havefound that it is characteristic 0 the contained sutureinvite excessive kinking particularly other relatively stiff I6Si ientsuture strands to kink when pulled longitudinally from a generally circular; or helical;

the point where the'stran'd 'isldamaged. We have found that withcirculanand helical coils .smaller jthan two inches in circumference kinkinglis commonly encountered particularlyi 'v'vitli relatively, fiat'packag es with. side dispensing There isfa naturaltend'e'ncy withside dispensing .of suture I strands froni circularand helical coils to reduce the diam-' eter of the immediate coil loop tothe point where a kink is formed it the loop cannot turn over.

The Clem'nson andihukens devices which were designed to be-'pnt n din-g a suture tube, outer. containers, have not,tlierefor'e, been widely acceptedbythe surgical'profesw' suture coils which is relatively fiat so as to fit comfortably in the surgeons palm and which will dispense catgut or other relatively stilt resilient suture strands progressive 1 1y as needed Without entanglement and with a minimum of kinking.

' comprising the package faces are joined'by interfitting fiapsof one panel into slots in the othen.

It is another object tively fiat suture coil packages with dual utility in dis-' 'pensing sutures and for ligating procedures which in some formsmay be suitable vfor use with glass tube suture outer packages, but which are particularly suitable for use in relatively flat envelope type suture outer packages.

Other objects and advantages of the invention ;will beapparent from the detailed description and the accom' I FIG. 1 illustrates, in plan, one type of suture coil package of this invention in which initiallvflat panels FIG. 2 illustrates, in plan, a preferred form of the in-.

vention in which circular superimposed'initially flat panels are sealed together around their peripheries to form the roughly circular coil form.

FIG. 3 illustrates, inplan, partlycut away, a coil pack- I age of this invention showing a relatively stiff resilient organic suture strand,c oiled in figure-eight form.

FIGS. 4, 4A, and v4B illusti atef in plan, the successive positions which the relatively stiifiresilient organic suture strand assumes, as the suture is fcdj in parallel to orat an acute angle with the package faces, to forrn the initial partment zcoil pack par tment.

I figure-eight of the suture coil of FIG. 3. 5

FIGL' 5 illustrate partly'in cross-section, isometricv1ew of a modification of FIG. 2 in which a two corn 1' FIG. 6 illustrates" alplan View oft-he coilpackag el FIG. 2. with a needle attached to the contained catg'ut suture.

tion wherein the package has somewhatgreater thickness. I In-the drawings, FIG. 1 illustrates'pne type of suture package 10 which consists of twoinitiallyfiatseparate,

panels, 11 and' 12 having interfitting tabs 13 and slots sion. 'Gl a ss suturetube packages, instead, have generally v contained'sutures ;wound upon H shaped reels typically 'illus'tfat ed in U,S.Pa tent1 No. 2,253,287 to Davis'et al.

A imodificationof thehfi 1 reel has threeprongs at each end with the suture, wound around the middle two prongs so as to lie generally inaplane parallel' to the plane of 'the reel body. v

14. After its assembly, thepackage may be filledwithlhe sutureIS by inserting the suture end 16 through the filling; and dispensinghole 17 and wedging it between the panels, orinto one of the slots 14, whereupon the suture, may;1 be fedendwise through the hole 17 and guided to form a:

' circular coil. The suture end 18 may be leftprotruding iron; hole 17 or it may be tucked into anOtherholelQ or into one'ofthe slots 14 if desired. Preferablythehole 17 is centrally located in panellZ from which position;

the suture may be loaded and dispensed more evenly. I

FIG, 2 shows a preferred form of the invention wherein. the suture package 20 is forrn'edpf circular initially fiat panels 21 and 22 sealed together around their peripheries.

In addition to the centrally located dispensing hole 23, 0ne' or both of the panels may also be provided with circula of the invention to provide relage holds a sutin'estrand each coma FIEIGS. 7 illustrates aimethod 'j 'filliiig a modification FIG. 8 illustrates *a further mtsdiaatam'e; m t;

'n ql te'i tion holes 24 which permit suture fluid. The end 16 of the suture coil 15 wedges ingress and egress of air and itself at some point into the acute angle formed by the two panels Where they join around their peripheries and the coil automaticallyforms itself as the suture is fed: endwise normal to panel 22 andinto' the hole23. The suture end 18 may be tucked into one of the circulation holes 24 if desired.

'FIGJB illustrates a suture packagefitlof this invention in which the suture strand is in the form of a figure-eight. It will be noted that the filling and dispensing hole 33 is located at one of the edges where the panels 31and32 join. This is'the preferred location for such a hole in 1 packages containing figure-eight coils, but as will be explained hereafter the hole may be in the face of onlyone of-the-panels as is illustrated in FIG. 7.

FIG. 4 illustrates a method of filling the package of the strand. Where the strand is a multifilament, it should have the same relative'stifliness and resiliency as any of the monofilaments in the givenranges to facilitate'filling the suturepack'age and to .permitthe strand to be withdrawn therefrom withoutkinking or .tangling. In general, the sutures resiliency and stiifness for thepackages of this invention should be such thatwhen thestrand is T formed into abend and the bending force is removed,

FIG. 3. The relatively stilf suture strandis fed endwise parallel to' or lat'an acute angle ,to the faces of the. package 30 through the stationary guide 34. As the a suture enters the package,- the suture end 116 strikes the .3: point of the package opposite the filling anddis'pensing At. this a point,

hole where the panels 31 and 32 meet. end 16 isheld by a temporary externally applied clamp 35. The progressiveformation of the initial loop of the; suture strand-36 is illustrated in FIG. 4A.v In FIG. 4J5 the progressive enlargement-of loop 57 is showmf, As more of the suture stran dis'fed intoth'e; package, a-sec-F ond loop is-formed to the left followed by a second loop 1 formed to the right etc., untilonly the end :portion 18' of the .suture remains in the guidei34; At this point,

the guide: is-removed,1as is=thec1amp35 andtheends 16 and 18 assumethe position shown in FIG. 3..

'In'QFIG. s 'a" modification of FlG. 2 is illustrated in which. the panel 22 of FIG. 2 ibecornesia common separation' and middle panel for a twocompartment suture I package with'ra panel 21 on one side and a'sirnilar'panelf 21a on the other side. This modification contains a suture 15 in onefof the two compartments and another:

suture 15a in the, other.

In-FIG. 6 is shown anothermodification of 1 1G112 i V in whichla needle 25 is shown attached to the end :18. I

of the suture; The needle is "shown with a protecting tip,-

26 .offdipped wax, polyethylene orotherplastic material I which may be easily; removed and which furnishes; pro-.

. tectio'n for. the; needle tipas well. as for the outer s'uture.

container if ,the latter is capable of; being damaged by the sharp point.

eight catgut suture coilinja package of this invention which. package has a hole 44in; panel 41 insteadofa V In FIG. .7 isillustrated a method ofrmakinga figureholeinthe edge of both panels 41 and 42. A curved 1 stationary guide may hejused with this modification,

especially with finesutures, in making a figure-eight: coil; .but stiffer sutures may be more readily coiled. into figureeight configuration witha straight, guide 43 inserted at.

In: FIG. 81is illustrated asuture package-10f" this invention wherein" the topypanel-45 andthe bottom panel 46 arejoin'ed .at their peripheries by an'interyening wall 47.f Withthis' type offpa'ckage'; the suture assumes a true.

helical winding with the. entering suture: end 16 forming a circular loop against thewall 47 and 'on'the bottom the suturestrand should have a definite tendency to return to its unbent condition. I I

The relatively. stitf resilient organic strand material for the coil packages of this invention is preferablyof a digestible proteinaceous nature such as thesurgical suture.

made of sheeps intestines commonly known as fcatgut,

outother organic strand material' with stiifnessjand re--. siliencycomparable to monofilament strands-within the giyen diameter: andinitial modulus ranges are suitable for thefcoil packages of the invention whether the strands.

are natural or synthetic in origin. A list-of} suitable materials whichis representative, but by no means exclusive, includes ,polyamides such as various nylons, polyesters suchaspolyethylene terephthalates andfvinylfpolymers and copolymers of vinylidene chloride, vinyl acetate and vinyl chloride, .polyolefins such as polyethylene, :polypropyleneand the'like, andacrylicssuch as acrylonitrile 'polymersp a I .The suture coil-packages of this inventionare formed of twoor more preferably initially flat superimposed panels, .with immediately adjacent-panelsfbeing joined in at leastthree points spaced-about the panel peripheries to form a compartment;

projects.

v Preferablyjthe flat: superimposed-.panelsof the suture I coil packages of thisv inventionmeetatftheir peripheries .45.,

(as is illustrated in FIG. 2) for reasons .of economy and convenience in use.- Suchpackagesmayabe made ofsoft pliable "material such as polyethylene in thin sheets}; How;

ever, in some einbo'diments. of the inventio n',;the;superimposed panels may be joined at-their peripheries by an intervening wall which provide'sisomewhat greater thickness to. the package as is illustrated. in FIG. 8. lnany event, when thecoilis'. substantially. circular as opposed to figure-eight shape, the fillingand dispensing holeis preferably centrally locatedintone of the;.superirnposed.. panels so that iti lies; near thexaxis. of the coil. As the. 1 .filling anddispensing hole is movedtowardltheperiphery of the panel, the-possibility of kinkingiduring suture dis-l pensing isfincreased with circular coils, andthis is true panel and each'succeedingllooplying against the wall 47- and atop the preceding loop.; r The dispensing 'end 181 of the suture projects from the fillingand dispensing hole Variouscommercial products of .myqinvent ion include resilient suture strands of naturalgor 'syntheticmaterial in'the stiffness rangeiof monofilament strands varying from, .001 1:01.05 inch in diameter .andhaving initial] moduli of-elasticity ranging fror'n 200,000 to"1', 200,000:' pounds per square inch as calculated from the stressstraincurve obtained onthe Instron Tensile Tester manu- I factured by.InstronfEngineering Company, Quincy 7-1,

I coil 5 circumference;

of packages ofthelkind illustrated in F1618 where. the" .depth of the package is not morethanone-founth ofthe fWe have found that.catgut orfothenrelatively stiif resilient organici sutures may. be. introduced into the coil packagesrof. this invention; preferably. progressively lengthwise-into thef filling; anddispensing holetjin one of. the superimposed lipanels whereupon the stiffness and springynature of the strand will. canse it to, bend. and "conform itself 1 to. the inside. :dimensions offthe coil package in such .a Way that consecutive, bendst'end .to befof maximumpossible diameterdepending upon the angle. of in-,

troduction, the] size and-:shapefof the; package and the stitfness'of the. strand. This characteristic of relatively 7 still organic; sutures permits; their subsequent progressive lengthwise withdrawal from the. packageseof.thisdnventiori without entanglement. For exannple,v whenj the. end :j'of

The coil package comprises one or more ofsuch coinpartments-eachhaving.a filling and dispensing aperture or.,hole', in one. of the superimv posed panels, frompwhi'chQan-end ofthe contained strand i or an extension. of the strand (such as anattached' needle),

a catgut suture is introduced perpendicularly to the panel 21 into the filling and dispensing hole 23 of FIG. 2, and progressive inward lengthwise suture motion is continued, the end portion bends and moves toward .the package edge where the end wedges itself into the space where panels 21 and 22 meet. With further progressive lengthwise introduction of catgut, the bight within the package conforms itself by winding (in this case) into the largest circle possible contacting the package walls, with the initial loop of catgut wedging into the restricted space near the points where the panels meet. If the external end of the catgut is not free to rotate, a single turn vof twist is introduced opposite to the direction of coiling into each loop as it coils (and an opposite untwistv is introduced as it is uncoiled). With continued introduction ofcatgut further loops are formed, each succeeding loop expanding into the available space consistent with its stiffness winding in contact with the walls of the package. As a consequence of this tendency of resilient suture strands to expand as much as possible into contactwith the package walls each loop stabilizes itself as it is formed so/that the package, with .its contained suture, tends to remain stable with very little tendency for the individual catgut loops to,become entangled,

. Where catgut or otherrelatively stiff resilient organic strand material is wound helically onto a turning mandrel to form a coil, no twist is normally introduced by the coiling. .When the-coil -is removed from the mandrel and placed in "a dispensing package where the helical coil is not free to turn, however, a longitudinal pull on the strand will introduce afull twist in the direction of coiling'for each-loop uncoiled, Obviously where the loop circumference is small, a high degree of accumulated twist is introduced which resists further twisting. This resistance may reach the point where the immediate loop instead of disappearing, by introducing a further twist, merely becomes smaller and smaller until a kink is 'formed. Where the dispensing hole is so located that the suture material as withdrawn from the coil is in a line, which is substantially parallel to the axis of the coil, then the tendency to kink is at a minimum. The farther away from parallelism the axis of the coil and the withdrawn line of the suture are, the greater the tendency is to kink especially where the loop being uncoiled is confined so that it cannot turn to bring the line to the dispensing hole more nearly into parallelism with its axis. We have found, however, that wherethe dispensing hole is centrally located near'theaxis of the coil and the coil is at least two inches in circumference the tendency to kink on dispensing is virtually eliminated.-

Catgut or other relatively stiff resilient organic strands may be dispensed in full 60 inch length from the pack ages of the invention, through the filling and dispensing hole readily and efficiently as needed without the users touching the portion still remaining in coiled condition or removing it from'the package.

the like, the outerend portion of the strand being used in tying off, after which the attached suture strand maybe severed near the-knot, thus attaining one of the primary advantages of this invention. By tying the knot is ligating strands inthe packages of this invention is determined largely by the stiffness of the suture, the angle of introduction of the suture into the package and the shape of the package.

Packages containing circular coils of resilient suture strands may be made in accordance with this invention by progressively moving a suture lengthwise into an aperture or hole in one of the two panels forming the faces of the package in such a way as will permit the suture to form itself freely into the package in a circular coil around the hole. Depending upon the stiffness of the resilient suture strand, the hole in the package may approach the edge of a panel rather closely and still a circular coil will be produced especially if av rotating guide is utilized which turns as the suture forms the circular coils. However, figure-eight coils will be produced if the suture is unable to form freely into a circular coil as when'a stiff suture is introduced at an acute angle or too near the panel edge. fore, and that which is preferredgis to locate the hole roughly centrally of one of the panels and use a fixed guide with the suture guide channel thereof normal to the face of the panel.

Packages of this invention having tively stiff resilient strands may be formed in the same manner as those containingfcircular coils, but the package in such cases should be slightly elongated. preferably being either rectangular or oval shaped.

Whereas the circular coils are preferred in the packages of this invention, it possible also,especially whereit is advantageous to usea narrow rectangular package, to have the relativelystiff resilient suture assume the formof a figure-eightcoil. Withsuc h coils it is highly desirable that the inner end of the suture'assume a position near the mid-portion of the package where the two panels meet, as is illustrated in FIG. 3, rather than near the r outer edge of the loops since in the former position it is made which are efficient in dispensing sutures without en- V The package may thus be held in one hand while ligating blood vessels and J.

tanglement and which are almost as readily usable as those with oval or circular coils. Such figure-eight packages are highly useful in ordinary glass suture tubes.

Packages of this invention containing figure-eight coils may be made in the manner preferred for circular coils by making the angle of introduction acute either at the edge or center of the top panel. Because of'the difficulty of controlling the entering end of catgut, however, it is preferred in forming figure-eight coils, to temporarily clamp the end of the suture utilizing the methods illustrated in FIG. 7 or that illustrated in FIGS. 4, 4A and 4B.

This application is a division of our copending application Serial No. 739,623, vfiled June 3, 1958, now Patent No. 3,062,372.

We claim: 1. The method ofv forming a continuousresilient organic suture into a repetitive series of substantially simigeometrically equilateral configuration or ofcircular shape are preferred because suitable-- packages can be attained with a shorter package sealing periphery and the least amount of packaging material and the bends in the suture coils contained in such packages convenientlymay be relatively large thus further minimizing the tendency to kink. In the packages of this invention containing circular suture coils, we prefer that the suture make a complete turn in slightly more than 3.5 inches.

The shape assumed by the coils of resilient suture lar geometric configurations within a relatively flat apertured compartment formed by the peripheral junction of two superimposed panels meeting at points near. their peripheries whereby said suture is freely dispensable,

comprising thrusting a suture end and progressively the adjacent end portion of said suture into said compartwith said end wedged whereby other end-adjacent porment to form a relatively flat repetitive series of substan- The simplest produce, there-.

oval coils of rela-.

tially; similaraigeometric configurations incontiguous relation'ship, with each configuration substantiallyparallel ing the planes of said panels, and terminating lengthwise thrust of said suture into said compartment with an end ofsaid suture remaining projecting therefrom.

2. The methodof claim l'whe'rein the apertured compartrnenthas acentrally disposed aperture in one of thepanels, the geometric configurations are substantially circular and wherein the suture in moving along one of said panels is caused to bend approximately 90'degreest from itsposition prior to contacting said panel along which it moves. .t V

3. The method of forminga continuous resilient, or-v ganicsuture into a repetitive series of substantially similar figure-eight configurations within a compartment of a relatively fiat'package formed by the junction of top and bottom super-imposed panels meeting at points near their peripheries,comprising introducing an end of the suture into said compartment through an aperture therein, moving :saidsuture end' and the, adjacent end portion of .20: said suture; progressivelyinto said compartment at an:

acute angle. to'the superimposed panels until said end is arrestednear the junction, of said panels, continuing to, move portions of said suture progressively lengthwise into said compartment with said end arrestedito thereby cause portions of the suture Within the compartment to bend and'assume the form of a figure-eight configuration deg termined byt the confines of the compartment, thereaftercontinuing to move portions of said suture progressively into said compartment to form, a repetitive series of similar figure-eight configurations-in contiguous relationship, with each-substantially paralleling the planes of said 1 8' panels, and stopping lengthwise movement of said suture ing' projecting therefrom. i

into said compartment Withan end of said sutureremain- I 4. The method (xi-"forming a continuous resilient or-,

ganic suture intoia repetitive series of substantially similarifigure-eight configurations Within a compartment of a relatively flat package formed by the junction of top and" bottonrsuperimposed panels meeting at points near vtheir peripheries, comprising introducing an end of the suture into said compartment through an aperture therein, mov-' ing said suture end and the adjacent endportionof said suture progressively into said compartment substantially parallel to the superimposed panels "until said end is atrested near the junctiontof said'panels, continuing to maining projecting therefrom.

into said compartment withijan end of said suture re- :3 j References Cited inthe file' of this patent UNITED sTATEs. AT NT 

1. THE METHOD OF FORMING A CONTINUOUS RESILIENT ORGANIC SUTURE INTO A REPETITIVE SERIES OF SUBSTANTIALLY SIMILAR GEOMETRIC CONFIGURATIONS WITHIN A RELATIVELY FLAT APERTURED COMPARTMENT FORMED BY THE PERIPHERAL JUNCTION OF TWO SUPERIMPOSED PANELS MEETING AT POINTS NEAR THEIR PERIPHERIES WHEREBY SAID SUTURE IS FREELY DISPENSABLE, COMPRISING THRUSTING A SUTURE END AND PROGRESSIVELY THE ADJACENT END PORTION OF SAID SUTURE INTO SAID COMPARTMENT CAUSING SAID END TO CONTACT AND MOVE ALONG ONE OF SAID PANELS AND WEDGE BETWEEN THE ACUTE ANGLE SAID PANELS FORM ADJACENT THEIR JUNCTURRE, CONTINUING TO THRUST SAID SUTURE PROGRESSIVELY LENGTHWISE INTO SAID COMPARTMENT WITH SAID END WEDGED WHEREBY OTHER END-ADJACENT PORTIONS OF THE SUTURE WITHIN THE COMPARTMENT ARE CAUSED TO BEND AND THE BENDS TO ENLARGE INTO THE PERIPHERAL CONFINES OF THE COMPARTMENT THEREBY WEDGING THEMSELVES INTO A GEOMETRIC CONFIGURATION, THEREAFTER CONTINUING TO THRUST SAID SUTURE PROGRESSIVELY LENGTHWISE INTO SAID COMPARTMENT TO FORM A RELATIVELY FLAT REPETITIVE SERIES OF SUBSTANTIALLY SIMILAR GEOMETRIC CONFIGURATIONS IN CONTIGUOUS RELATIONSHIP, WITH EACH CONFIGURATION SUBSTANTIALLY PARALLELING THE PLANES OF SAID PANELS, AND TERMINATING LENGTHWISE THRUST OF SAID SUTURE INTO SAID COMPARTMENT WITH AN END OF SAID SUTURE REMAINING PROJECTING THEREFROM. 